SELLAS Life Sciences Highlights 2020 Business and Clinical Progress and 2021 Milestones
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NEWS RELEASE
SELLAS Life Sciences Highlights 2020 Business and
Clinical Progress and 2021 Milestones
1/14/2021
- Phase 3 REGAL Study of Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML) Patients Underway in United
States and Europe -
- License Agreement with 3D Medicines for Development and Commercialization of GPS in China Initiates
Commercialization Strategy for GPS -
- Balance Sheet Signi cantly Strengthened in 2020 with Preliminary and Unaudited Cash and Cash Equivalents of
$35.3 Million as of December 31, 2020 -
NEW YORK, Jan. 14, 2021 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the
“Company”), a late-stage clinical biopharmaceutical company focused on the development of novel cancer
immunotherapies for a broad range of cancer indications, today highlighted its business and clinical progress in
2020 and expected 2021 milestones.
“2020 was a transformative year for SELLAS as we commenced the pivotal Phase 3 REGAL study of GPS in patients
with AML who have achieved complete remission after second-line anti-leukemic therapy (CR2) in the United States
and Europe and also announced important clinical data in the same patient cohort from our completed Phase 2
study showing a median overall survival of 21 months vs. 5.4 months in favor of patients who received GPS, with a
p-value of 0.02. We are also intrigued by the recently announced initial data from two studies of GPS in combination
with checkpoint inhibitors in ovarian and malignant pleural mesothelioma indications, and we look forward to
providing further data from these studies in the rst half of 2021. We were also pleased to present last month at
the 2020 San Antonio Breast Cancer Symposium positive nal data with up to 6 months follow-up from the
randomized Phase 2 trial (the VADIS study) of nelipepimut-S (NPS) in combination with granulocyte-macrophage
1colony-stimulating factor (GM-CSF) in women with ductal carcinoma in-situ of the breast showing immune
stimulation augmented by +1,300% at 6-months post-NPS treatment and a statistically signi cant di erence of
duration of immune response of NPS vs. control with a p-value of 0.000094,” stated Angelos Stergiou, MD, ScD h.c,
President and Chief Executive O cer of SELLAS.
“Additionally, we began preparations for the commercialization of GPS, assuming we achieve positive data from the
REGAL study, with a collaboration with 3D Medicines Inc. for the development and commercialization of GPS in
Greater China which we announced at the end of 2020. This licensing transaction with 3D Medicines for GPS has
been ranked by PharmaCube, a leading Chinese database, as one of the top ten life sciences licensing transactions
in China in 2020 in terms of the total nancial consideration,” commented Dr. Stergiou.
“Importantly, we strengthened our balance sheet in 2020 with gross proceeds of approximately $47.9 million from
the sale of securities, exercise of warrants, and the upfront payment from 3D Medicines and we ended the year
with approximately $35.3 million in cash and cash equivalents. The proceeds from these transactions will
signi cantly support the GPS clinical programs,” added Dr. Stergiou.
2020 Clinical Highlights and 2021 Milestones
Galinpepimut-S (GPS)
In December 2020, the Company announced initial clinical data for GPS in combination with checkpoint
inhibitors in two solid tumor indications in patients with advanced solid cancers who had exhausted their
standard therapy options. In the Company’s Phase 1/2 open-label study of GPS in combination with Merck’s
anti-PD-1 therapy pembrolizumab (Keytruda®) in patients with selected advanced Wilms Tumor 1 positive
(WT1+) cancers, the rst set of evaluable patients (n = 8) diagnosed with 2nd or 3rd line WT1(+) relapsed or
refractory metastatic ovarian cancer demonstrated a disease control rate (the sum of overall response rate
and rate of stable disease) of 87.5% with a median follow-up of 9.4 weeks and, at the rst assessment time-
point of 6 weeks post-therapy initiation, 100% of the patients were free of disease progression. In the
Company’s Phase 1 investigator-sponsored clinical trial (IST) of GPS in combination with the checkpoint
inhibitor nivolumab (Opdivo®) in patients with macroscopic measurable deposits of malignant pleural
mesothelioma (MPM) who were either refractory to or relapsed after frontline tri-modality standard therapy,
the rst set of evaluable patients (n = 3) had a median progression free survival of at least 10 weeks since
therapy initiation. Updated data on both studies are expected in rst half of 2021.
In December 2020, the Company announced that it had entered into an exclusive license agreement with 3D
Medicines Inc., a China-based biopharmaceutical company developing next-generation immuno-oncology
2drugs, for the development and commercialization of GPS, as well as the Company’s next generation
heptavalent immunotherapeutic GPS+, which is at preclinical stage, across all therapeutic and diagnostic uses
in the Greater China territory (mainland China, Hong Kong, Macau and Taiwan). SELLAS retains sole rights to
GPS and GPS+ outside of the Greater China area. Potential payments to SELLAS under the agreement in
licensing fees and milestone payments, not including potential future royalties, could total $202 million,
including an upfront license fee of $7.5 million paid in December 2020.
In September 2020, SELLAS announced that it received approval of its Investigational Medicinal Product
Dossier (IMPD) from the French regulatory authority, Agence Nationale de Sécurité du Médicament et des
Produits de Santé (ANSM), to advance in France its pivotal Phase 3 REGAL study of GPS in AML CR2 patients.
The Company has subsequently received IMPD approval from the German health authorities and expects
approvals from additional European health authorities in early 2021 which will allow SELLAS to expand AML
patient enrollment for the pivotal Phase 3 REGAL study of GPS in Europe.
In the spring of 2020, the Company established an Independent Data Monitoring Committee (DMC) of leading
clinical and biostatistics experts to review and evaluate patient safety and e cacy data for the Phase 3 REGAL
trial and also appointed a Steering Committee of leading AML experts for the study. The DMC is responsible
for reviewing and evaluating patient safety and e cacy data and will review study data at regular intervals in
order to ensure the safety of all patients enrolled in the study. The Steering Committee will provide scienti c
oversight and guidance of the practical aspects of the study and will make recommendations regarding the
monitoring of the study in consultation with the DMC.
In February 2020, the Company announced positive nal follow-up data from its Phase 2 clinical trial of GPS in
AML CR2 patients. The nal data showed a median overall survival (OS) of 21.0 months, at a median follow-up
of 30.8 months, in patients receiving GPS therapy compared to 5.4 months in the AML CR2 patients treated
with best standard care, a statistically signi cant di erence (p-value < 0.02). Final analysis showed that GPS
therapy continued to be well-tolerated throughout the study. The Company previously reported initial data
from this Phase 1/2 study at a median follow-up of 19.3 months, showing median OS in GPS-treated patients
of 16.3 months vs. 5.4 months in a patient cohort contemporaneously treated with best standard therapy (p =
0.0175).
Nelipepimut-S (NPS)
In December 2020, the Company announced positive nal data with up to 6 months follow-up from the
randomized Phase 2 trial (the VADIS study) of NPS in combination with granulocyte-macrophage colony-
stimulating factor (GM-CSF) in women with ductal carcinoma in-situ (DCIS) of the breast who are HLA-A2+ or
A3+ positive, express HER2 at IHC 1+, 2+, or 3+ levels, and are pre- or post-menopausal. This IST randomized
3patients to receive, prior to surgery, either GM-CSF followed by NPS two weeks later or GM-CSF alone.
Preliminary data previously reported showed that treatment with even a single dose of NPS was capable of
newly inducing NPS-speci c cytotoxic T-lymphocytes (CTLs) in peripheral blood in DCIS patients. The updated
data, based on a 6-month follow-up, demonstrate that CD8+ T-cell responses persist long-term post-NPS
treatment, with treated patients retaining and modestly enhancing their antigen-speci c immune response.
When compared to baseline (BL), i.e., prior to investigational agent administration, the relative frequency of
NPS-speci c CD8 CTLs as a percentage (NPS-CLT%) in peripheral blood at the 1-month and 6-month post-
operative time-points increased in the NPS+GM-CSF group (n=9) by 11- and 14-fold: 0.01+0.02% [BL] vs.
0.11+0.12% [1-mo] and 0.14+0.12% [6-mo], respectively, while in the GM-CSF alone group (n=4) the NPS-CLT%
in peripheral blood increased by only 2.25- and 3.75-fold: 0.04+0.07% [BL] vs. 0.09+0.15% [1-mo] and
0.15+0.03% [6-mo], respectively. For the NPS+GM-CSF group, the di erences in absolute NPS-CTL% mean
values between baseline and 1- or 6-months post-vaccination were statistically signi cant, with p-values of
0.039 and 0.0125, respectively. The relative change in NPS-CTL% mean values at 6 months post-vaccination
was +1,300+450% for the NPS+GM-CSF group vs. 250+150% in the GM-CSF alone group, which was highly
statistically signi cant in favor of the NPS+GM-CSF group: p=0.000094. These data were presented at the San
Antonio Breast Cancer Symposium on December 11, 2020.
Financial Summary
The Company’s preliminary and unaudited cash and cash equivalents as of December 31, 2020 was approximately
$35.3 million. The estimated cash and cash equivalents as of December 31, 2020 are preliminary and may change,
are based on information available to management as of the date of this press release, and are subject to
completion by management of the nancial statements as of and for the year ended December 31, 2020. There can
be no assurance that the cash and cash equivalents as of December 31, 2020 will not di er from these estimates.
Complete annual results will be included in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2020.
About SELLAS Life Sciences Group, Inc.
SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel cancer
immunotherapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from
Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types.
GPS has potential as a monotherapy or in combination to address a broad spectrum of hematologic malignancies
and solid tumor indications. SELLAS’ second product candidate, NPS, is a HER2-directed cancer immunotherapy
with potential for the treatment of patients with early-stage breast cancer with low to intermediate HER2
expression, otherwise known as HER2 1+ or 2+, which includes triple negative breast cancer patients, following
standard of care.
4For more information on SELLAS, please visit www.sellaslifesciences.com.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth,
N.J., USA, and is not a trademark of SELLAS. The manufacturer of this brand is not a liated with and does not
endorse SELLAS or its products. Opdivo® is a registered trademark of Bristol Myers Squibb, and is not a trademark
of SELLAS. The manufacturer of this brand is not a liated with and does not endorse SELLAS or its products.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts are
“forward-looking statements,” including those relating to future events. In some cases, forward-looking statements
can be identi ed by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,”
“believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning.
These statements include, without limitation, statements related to the clinical development of GPS for various
cancer indications, including AML, ovarian cancer and MPM, the potential for regulatory approval and
commercialization of GPS, statements related to the clinical development of NPS for breast cancer, including DCIS.
These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions,
and inherently involve signi cant risks and uncertainties. Actual results and the timing of events could di er
materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties,
which include, without limitation, risks and uncertainties associated with the COVID-19 pandemic and its impact on
the Company’s clinical plans, risks and uncertainties associated with immune-oncology product development and
clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties a ecting SELLAS
and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K
led on March 13, 2020 and in its other SEC lings. Other risks and uncertainties of which SELLAS is not currently
aware may also a ect SELLAS’ forward-looking statements and may cause actual results and the timing of events to
di er materially from those anticipated. The forward-looking statements herein are made only as of the date
hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to re ect actual
results, new information, future events, changes in its expectations or other circumstances that exist after the date
as of which the forward-looking statements were made.
Investor Contacts
Adam Holdsworth
PCG Advisory
917-497-9287
adamh@pcgadvisory.com
5Investor Relations
SELLAS Life Sciences Group, Inc.
917-438-4353
info@sellaslife.com
Source: SELLAS Life Sciences Group
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